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NCT06222099 · ClinicalTrials.gov registry record · NA
The HEARTFELT Study
A NA study of Heart Failure and Chronic Heart Failure, sponsored by Heartfelt Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 1,500
- Enrollment target
- 3
- Study locations
NCT06222099 is a NA study of Heart Failure and Chronic Heart Failure that is actively recruiting participants, run by Heartfelt Technologies. The registered enrollment target is 1,500 participants, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06222099, a NA study of Heart Failure and Chronic Heart Failure, is actively recruiting participants, sponsored by Heartfelt Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,500 participants
- Enrollment target
- 3
- Study locations
Study Summary
This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.
Conditions Studied
Interventions
- OTHER Questionnaires
- OTHER Standard care
- DEVICE Heartfelt Device installed
- DEVICE Heartfelt-guided care
Study Locations (3)
Georgia
- Rimidi - Atlanta
New Jersey
- HealthArc - Hackensack
Pennsylvania
- Connect America - Bala-Cynwyd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2025-10-23 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06222099
The ClinicalTrials.gov registry entry for NCT06222099 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The listed sponsor is Heartfelt Technologies, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 4 interventions - of which Questionnaires is the first listed.
NCT06222099 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06222099 about?
NCT06222099 is a clinical study titled "The HEARTFELT Study". This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to b...
What is the current status of trial NCT06222099?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2025-10-23. Estimated completion is 2030-12-31.
What conditions does trial NCT06222099 study?
This clinical trial studies the following conditions: Heart Failure, Chronic Heart Failure.
What interventions are being tested in trial NCT06222099?
The interventions under investigation include: Questionnaires (OTHER), Standard care (OTHER), Heartfelt Device installed (DEVICE), Heartfelt-guided care (DEVICE).
Who is sponsoring clinical trial NCT06222099?
This trial is sponsored by Heartfelt Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06222099 being conducted?
This trial has 3 study locations across Georgia, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.